MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2023 by a sales representative via sems that an ar-613-1 tka handle broke.Case involvement, device broke during use.All fragments removed.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual evaluation, it was noted that the strike cap is detached from the shaft, showing that the weld broke.However, the pieces were not returned for investigation.The cause remains undetermined.

• Brand Name: IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16466128
• Report Number: 1220246-2023-06366
• Device Sequence Number: 7671921
• Product Code: LXH
• UDI-Device Identifier: 00888867115941
• UDI-Public: 00888867115941
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH
• Device Catalogue Number: AR-613-1
• Device Lot Number: 051845
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown